BTS S.p.A. – FDA Warning Letter, Feb 2, 2012

On January 30 - February 2, 2012, an FDA inspection of BTS S.p.A. in Padova, Italy, found that their FreeEMG and PocketEMG devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's February 14, 2012, response to the FDA 483 was deemed inadequate for most observations.

Key violations include: 1. **Design Validation (21 CFR 820.30(g))**: Failure to document design validation results (e.g., dates, personnel, and adherence to protocols) for the FreeEMG. The firm re-performed tests but lacked systemic corrective action. 2. **Design Review (21 CFR 820.30(e))**: Failure to plan and document formal design reviews at appropriate stages. Procedures were amended, but systemic corrective action was not demonstrated. 3. **Complaint Handling (21 CFR 820.198(a)(3))**: Inadequate procedures for evaluating complaints for Medical Device Reporting (MDR) reportability. Procedures were revised, but employee training and review of past complaints for MDR were not evidenced. 4. **Acceptance Activities (21 CFR